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Aug. 31 — Drug and device manufacturers will soon have a chance to tell the FDA directly about
changes they’d like to see the agency make to its off-label communications policy.

The FDA regulates what device and drug manufacturers can tell health-care professionals
about the off-label use of those products—uses the FDA hasn’t specifically approved
them for.

The Food and Drug Administration will
hold a two-day meeting on off-label communications Nov. 9-10, according to a notice to
be published in the Federal Register Sept. 1. The meeting will take place right after
the presidential election, but written comments aren't due until Jan. 9, 2017. Any
FDA policy announcement on the issue probably won't be forthcoming until after the
new administration reviews it.

Regardless of the timing of any policy changes, the meeting is a welcome first step
for the drug and device industries, which have been pushing the FDA to clarify its
policy in this area for a long time.

“Removing current regulatory barriers, and clarifying the ability of companies to
share truthful and nonmisleading information about medicines, is essential to our
collective ability to realize the full potential of 21st century medicines and helping
to ensure that patients are able to get the right medicines at the right time for
them,” she added.

The drug industry's lobbying group, PhRMA, said in an Aug. 31 statement that it's
“pleased that FDA has recognized that ‘relevant, truthful, and non-misleading scientific
or medical information regarding unapproved uses of approved medical products may
help health care professionals make better individual patient decisions.’ ”

“[G]reater sharing of information between biopharmaceutical companies, payers and
health care professionals can benefit patient care and insurance coverage by ensuring
more patients receive the best treatment for them,”
Andrew Powaleny, the Pharmaceutical Research and Manufacturers of America's senior
manager for communications, said.

Limits Still Needed

Meanwhile, Public Citizen told Bloomberg BNA that limits on off-label communications
are still needed.

“Without strong limits on such industry communications, our long-standing regulatory
framework for ensuring that drugs and medical devices are safe and effective for their
intended uses would be undermined, threatening patient health,” Carome added.

Industry Still Awaiting Guidance

Under long-standing policy at the FDA, companies can be subject to criminal prosecution
and civil liability if they promote their products for uses the FDA hasn’t specifically
approved. The agency had promised to issue revised guidance by the end of 2014, but
industry is still waiting.

“The industry for years has been focused on this issue and has been pushing the FDA
to issue additional guidance on this topic,” Carome said. “The agency’s notice provides
a nice overview of the scope of the topic and appropriately poses key questions that
need to be considered.”

Similarly, Richard Samp, chief counsel of the Washington Legal Foundation, told Bloomberg
BNA Aug. 31 that “the broad set of questions posed by FDA” in the announcement “are
thoughtful and suggest that FDA is addressing many of the appropriate issues that
will affect its new off-label speech policy.”

FDA's Court Losses

Meanwhile, recent court cases challenging the constitutionality of the agency's off-label
promotion regulations have raised doubts about whether the federal government can
continue to restrict manufacturers from sharing truthful information about the off-label
uses of drugs and medical devices.

In the past, Samp said, “FDA has adopted unrealistic definitions of truthfulness.”
And, he said, the agency's restrictive definitions of truthful speech wouldn't pass
muster under the First Amendment.

“As WLF has argued many times, the First Amendment does not tolerate such a restrictive
definition of truthful speech, nor is that the way the scientific community has ever
operated,” Samp said.

First Amendment Issues

Samp observed that the FDA's questions don't mention the First Amendment at all.

“FDA obviously recognizes that its extended losing streak in the courts on First Amendment
issues requires the current re-examination of agency policy,”
he said. “Accordingly, I think it’s important for FDA to seek as much input as possible
regarding First Amendment policy.”

But Samp said he's pleased that the FDA’s questions “seemed to contemplate that different
standards ought to be applied to off-label speech depending on the audience.”

“WLF has long argued that in light of the reduced danger that truthful speech may
mislead when it is directed at doctors, FDA restrictions on such speech should be
minimized,” he said.

WLF is a Washington-based public interest group with a free-market/free-enterprise
orientation. WLF has been the named plaintiff in several cases challenging government
policy on off-label promotion.

“It's time for the agency to take back this issue from the courts,” John Kamp, consulting
counsel to Wiley Rein LLP and executive director of the Coalition for Healthcare Communication
in New York, told Bloomberg BNA Aug. 31. “Sooner would have been better,” he said,
“but the fact that they're serious and moving ahead is a good sign for the agency.”

To contact the reporter on this story: Dana A. Elfin in Washington at
delfin@bna.com

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